NCT03233932

Brief Summary

A randomized, open-label, single dose, parallel design phase I clinical trial to investigate the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplin Inj. 3.75mg after subcutaneous injection in postmenopausal female.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
Last Updated

July 31, 2017

Status Verified

July 1, 2017

Enrollment Period

1.2 years

First QC Date

May 23, 2016

Last Update Submit

July 26, 2017

Conditions

Postmenopausal Disorder

Keywords

CKD-841LeuplinPostmenopausal

Outcome Measures

Primary Outcomes (8)

  • Peak Plasma Concentration (Cmax) of Leuprorelin

    Peak Plasma Concentration (Cmax) in ng/mL

    From before injection to up to 1008 hours post injection

  • Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) of Leuprorelin

    Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) in ng•hr/mL

    From before injection to up to 1008 hours post injection

  • Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) of Leuprorelin

    Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) in ng•hr/mL

    From before injection to up to 1008 hours post injection

  • Area Under the plasma drug Concentration-time curve from 7 day to last measurement (AUC7-t) of Leuprorelin

    Area Under the plasma drug Concentration-time curve from 7 day to last measurement (AUC7-t) in ng•hr/mL

    From before injection to up to 1008 hours post injection

  • The time -to-maximal serum or plasma concentrations (Tmax) of Leuprorelin

    The time -to-maximal serum or plasma concentrations (Tmax) in hr

    From before injection to up to 1008 hours post injection

  • Terminal half-life (t1/2) Luteinizing Hormone(LH) of Leuprorelin

    Terminal half-life (t1/2) Luteinizing Hormone(LH) in IU/L

    From before injection to up to 1008 hours post injection

  • Follicular Stimulating Hormone(FSH) of Leuprorelin

    Follicular Stimulating Hormone(FSH) in IU/L

    From before injection to up to 1008 hours post injection

  • Estradiol of Leuprorelin

    Estradiol in pg/ml

    From before injection to up to 1008 hours post injection

Secondary Outcomes (1)

  • Safety Assessment by evaluating adverse events(AEs).

    From day1 to day 56

Study Arms (2)

LeuplinⓡInj

ACTIVE COMPARATOR

LeuplinⓡInj(=leuprorelin acetate 3.75mg)

Drug: LeuplinⓡInj

CKD-841

EXPERIMENTAL

CKD-841(=leuprorelin acetate 3.75mg)

Drug: CKD-841

Interventions

LeuplinⓡInjDRUG

Investigational drug(=LeuplinⓡInj)is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.

LeuplinⓡInj
CKD-841DRUG

Investigational drug(=CDK-841) is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.

CKD-841

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy menopausal female
  • β-hCG is negative at screening and before administration of investigational drug
  • Infertility by sterilization operation before 5 months from screening excluding ovarian cancer, uterine cancer etc...
  • Bwt ≥ 50Kg and Body Mass Index (BMI) ≥ 18.5 and \< 25

You may not qualify if:

  • History or current condition of disease related to Hepato-biliary system, renal system, nervous system, mental illness, immune system, respiratory system, endocrine system, hemato-oncology, circulatory system, musculoskeletal system or except for that, significant clinical disease
  • Uncontrolled diabetes mellitus
  • Pregnancy or breast feeding
  • History of taking medicine such as Leuprorelin acetate or similar affiliation drug within 12 weeks before administration of investigational drug
  • Has hypersensitivity to the active ingredient or excipients or same affiliation drug of the investigational drug, hypersensitivity of a medicine contained gelatin especially
  • Has abnormal function of liver and kidney at screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Yonsei-ro, Seodaemun-gu 50-1, 03722, South Korea

Location

Study Officials

  • Min Soo Park, Ph.D

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2016

First Posted

July 31, 2017

Study Start

April 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 31, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)